The Probiotic for Oral Health (PRO Health) Study



Status:Recruiting
Healthy:No
Age Range:21 - 45
Updated:3/3/2019
Start Date:September 4, 2018
End Date:August 14, 2019
Contact:Jennifer Smilowitz
Email:jensm@ucdavis.edu
Phone:530-752-1057

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The PRO Health Study is a single-center, prospective, double-blind, randomized,
placebo-controlled trial of streptococcus-containing supplementation in healthy adults.

Upon enrollment, healthy adults will enter a 1-week lead-in period which serves as an
opportunity to collect baseline saliva samples and complete daily logs. Subjects that meet
eligibility criteria on Day 7 will be randomized into 1 of 2 groups, receiving either a
placebo-control or a streptococcus-containing probiotic supplement. Supplementation will
begin on Day 8 and will continue for a total of 14 consecutive days. Participants will be
observed for an additional 2 weeks following cessation of supplementation. The total duration
of the study will be approximately 5 weeks. Saliva samples will be collected on 7 occasions
and participants will be asked to complete questionnaires and daily diet and health logs
throughout the course of the study.

Inclusion Criteria:

- Healthy adults;

- Age 21-45 years of age;

- BMI between 18-30;

- No history of infectious disease; heart, metabolic, autoimmune endocrine, liver, or
kidney diseases; GI related conditions such as malabsorption disease, Crohn's disease,
colitis, inflammatory bowel disease; Type 1 or 2 diabetes mellitus, any type of
cancer, heart disease;

- Practices good oral hygiene according to the American Dental Association with brushing
teeth between 1-2 times per day;

- Willingness to only use the study toothpaste to brush or clean teeth and refrain from
using any other oral-care products such as other toothpaste, mouthwash, rinses and
breath-sprays during the five-week study period;

- Willingness to limit consumption of raw onions or garlic and fermented foods such as
sauerkraut, pickles, miso, and kimchi during the five-week study period;

- Non-alcohol consumers or those who consume alcohol in moderation defined as having up
to 1 drink per day for women and up to 2 drinks per day for men;

- Willingness to avoid binge drinking during the study period defined by the CDC as:
This pattern of drinking usually corresponds to 5 or more drinks on a single occasion
for men or 4 or more drinks on a single occasion for women, generally within about 2
hours;

- Willingness to refrain from drinking any alcohol within 24 hours of each saliva sample
collection;

- Willingness to refrain from using illicit drugs during the five-week study;

- Willingness to refrain from using tobacco (smoking or chewing) or smoking marijuana
during the five-week study period;

- Willingness to refrain from intake of probiotics, kombucha, or yogurt during the
five-week study period;

- Willingness to refrain from consuming more than 1 package of sugary candy and from
chewing more than 1 package of chewing gum during the five-week study period;

- Willingness to refrain from having any non-emergency, elective oral surgeries, dental
procedures or dental teeth cleanings during the five-week study period.

Exclusion Criteria:

- Currently pregnant or plans to become pregnant several weeks prior to enrollment and
during the five-week study period;

- History of periodontal disease, or gingivitis;

- Dental trauma or injury to the teeth and/or periodontium (gums, periodontal ligament,
alveolar bone), and nearby soft tissues such as the lips, tongue within the past 4
weeks;

- Any oral surgery or intensive procedures made to the oral cavity (such as fillings,
wisdom tooth extraction, root canal, dental implants, etc.) within the past 4 weeks;

- Routine dental cleaning within the past 4 weeks;

- Use of probiotics, kombucha, or yogurt/kefir within the past 7 days of enrollment;

- Use of probiotics containing S. salivarius within the past 8 weeks of enrollment;

- Use of oral or IV antibiotics within the past 8 weeks of enrollment;

- Consumption of more than one package of sugary candy (hard candy, gummy candy, mints,
etc.) per day;

- Use of more than one package of chewing gum (sugary or sugarless) per day;

- Use of mouthwashes, mouth-rinses or breath-sprays more than three times per day;

- Current tobacco (smoking or chewing) or E-cigarette users or individuals who quit
using less than one year before enrolling in the study;

- Frequent marijuana smoking or vaping, or use of other illicit drugs (must be no more
than 12 times within the past year and no more than once per month);

- Marijuana smoking or vaping or use of other illicit drugs within the past 4 weeks;

- Excessive alcohol drinkers: For men, heavy drinking is typically defined as consuming
15 drinks or more per week. For women, heavy drinking is typically defined as
consuming 8 drinks or more per week;

- Individuals who live within the same household or who are in intimate relationships
with current or past study participants (to avoid horizontal transfer of the oral
microbiome);

- Anyone the investigator feels isn't an applicable participant.
We found this trial at
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Davis, California 95616
Phone: 530-752-1057
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